AstraZeneca’s naloxegol marketing application accepted by EMA

The European Medicines Agency has accepted Anglo-Swedish drug major AstraZeneca’s (LSE: AZN) Marketing Authorization Application for naloxegol for the treatment of opioid-induced constipation (OIC) for adult patients, including those with inadequate response to laxatives.

The MAA filing was based on comprehensive data from the core Phase III KODIAC program, comprised of four clinical trials designed to investigate the safety and efficacy of naloxegol for the treatment of OIC. Two pivotal Phase III studies, KODIAC-04 (n=652) and KODIAC-05 (n=700), both 12-week, multicenter, randomized, double blind, placebo-controlled trials, evaluated 12.5 mg and 25 mg doses of naloxegol administered once-daily. KODIAC-07 was a 12-week safety extension of KODIAC-04, and KODIAC-08 (n= 534) was an open-label, randomized, 52-week, long-term safety trial.

Authorization triggers $25 million payment